Cleared Abbreviated

K180661 - SIGMA Sterilization Pouch and Roll (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K180661 · Sigma Medical Supplies Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
83d
Days
Class 2
Risk

K180661 is an FDA 510(k) clearance for the SIGMA Sterilization Pouch and Roll. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Sigma Medical Supplies Corp. (New Taipei City, TW). The FDA issued a Cleared decision on June 5, 2018 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sigma Medical Supplies Corp. devices

Submission Details

510(k) Number K180661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date June 05, 2018
Days to Decision 83 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 128d · This submission: 83d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 319
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K180661.
Sterilization Pouch/Roll
K251347 · Sterivic Medical Co., Ltd. · Jan 2026
Self-Seal Sterilization Pouch and Roll
K251177 · Guangdong Maidi Medical Co., Ltd. · Dec 2025
Chex-All Sterilization Pouches and Tubes
K250306 · Propper Manufacturing Co., Inc. · Oct 2025
Sterilization Pouch and Roll
K243179 · Yichang Xinxin Paper Products Co., Ltd. · Jun 2025
GCI Sterilization Wrappers
K250321 · George Courey, Inc. · Jun 2025
Self Sealing Sterilization Pouches
K243721 · Wellmed Dental Medical Supply Co., Ltd. · Apr 2025